Podcast on Self-administered Intranasal Etripamil for Symptomatic Paroxysmal Supraventricular Tachycardia: The RAPID Trial
Abstract Paroxysmal supraventricular tachycardia (PSVT) is commonly seen in clinical practice and represents a significant burden to the healthcare system and to patients. First-line treatments include calcium channel blockers (CCB), although they are intravenous and require medical supervision. Etr...
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| Format: | Article |
| Language: | English |
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Adis, Springer Healthcare
2023-11-01
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| Series: | Cardiology and Therapy |
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| Online Access: | https://doi.org/10.1007/s40119-023-00335-4 |
| _version_ | 1797397669991153664 |
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| author | Bruce S. Stambler James E. Ip |
| author_facet | Bruce S. Stambler James E. Ip |
| author_sort | Bruce S. Stambler |
| collection | DOAJ |
| description | Abstract Paroxysmal supraventricular tachycardia (PSVT) is commonly seen in clinical practice and represents a significant burden to the healthcare system and to patients. First-line treatments include calcium channel blockers (CCB), although they are intravenous and require medical supervision. Etripamil is an investigational self-administered intranasal L-type CCB for unsupervised treatment of PSVT. In this podcast, we discuss the RAPID trial (NCT03464019), which was a phase 3 study that evaluated the safety and efficacy of etripamil in terminating PSVT episodes using a repeat-dosing regimen. RAPID was a multicenter, randomized trial that enrolled adults with electrocardiograph (ECG)-documented PSVT episodes lasting ≥ 20 min. Patients who tolerated test doses of etripamil were randomized 1:1 to receive either etripamil or placebo. Upon perceiving PSVT symptoms, patients began ECG monitoring and performed a vagal maneuver. If arrhythmia termination was unsuccessful, they self-administered 70 mg of etripamil or placebo, followed by an optional second dose after 10 min. The primary endpoint was time to conversion of PSVT to sinus rhythm within 30 min of the initial dose and sustained for ≥ 30 s. The safety group included all patients who self-administered the study treatment. Of 692 enrollees, 184 self-administered the study drug (99 etripamil, 85 placebo) for ECG-confirmed PSVT. Conversion of PSVT to sinus rhythm within 30 min was achieved in 64.3% of etripamil-treated subjects versus 31.2% of placebo-treated subjects. A significant threefold reduction in the median time to conversion of 17.2 min was observed in the etripamil group versus 53.5 min in the placebo group. Treatment-emergent adverse events were mild or moderate and primarily included transient nasal discomfort, nasal congestion, and rhinorrhea. If etripamil is approved by the US FDA, it can potentially address a significant unmet need for PSVT treatment outside a clinical setting, reducing the need for intravenous treatments that require medical supervision. Podcast available for this article. |
| first_indexed | 2024-03-09T01:14:29Z |
| format | Article |
| id | doaj.art-449121dac5784dd583c30e59b111d21b |
| institution | Directory Open Access Journal |
| issn | 2193-8261 2193-6544 |
| language | English |
| last_indexed | 2024-03-09T01:14:29Z |
| publishDate | 2023-11-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Cardiology and Therapy |
| spelling | doaj.art-449121dac5784dd583c30e59b111d21b2023-12-10T12:35:22ZengAdis, Springer HealthcareCardiology and Therapy2193-82612193-65442023-11-0112454555510.1007/s40119-023-00335-4Podcast on Self-administered Intranasal Etripamil for Symptomatic Paroxysmal Supraventricular Tachycardia: The RAPID TrialBruce S. Stambler0James E. Ip1Piedmont Heart InstituteWeill Cornell Medicine, New York Presbyterian HospitalAbstract Paroxysmal supraventricular tachycardia (PSVT) is commonly seen in clinical practice and represents a significant burden to the healthcare system and to patients. First-line treatments include calcium channel blockers (CCB), although they are intravenous and require medical supervision. Etripamil is an investigational self-administered intranasal L-type CCB for unsupervised treatment of PSVT. In this podcast, we discuss the RAPID trial (NCT03464019), which was a phase 3 study that evaluated the safety and efficacy of etripamil in terminating PSVT episodes using a repeat-dosing regimen. RAPID was a multicenter, randomized trial that enrolled adults with electrocardiograph (ECG)-documented PSVT episodes lasting ≥ 20 min. Patients who tolerated test doses of etripamil were randomized 1:1 to receive either etripamil or placebo. Upon perceiving PSVT symptoms, patients began ECG monitoring and performed a vagal maneuver. If arrhythmia termination was unsuccessful, they self-administered 70 mg of etripamil or placebo, followed by an optional second dose after 10 min. The primary endpoint was time to conversion of PSVT to sinus rhythm within 30 min of the initial dose and sustained for ≥ 30 s. The safety group included all patients who self-administered the study treatment. Of 692 enrollees, 184 self-administered the study drug (99 etripamil, 85 placebo) for ECG-confirmed PSVT. Conversion of PSVT to sinus rhythm within 30 min was achieved in 64.3% of etripamil-treated subjects versus 31.2% of placebo-treated subjects. A significant threefold reduction in the median time to conversion of 17.2 min was observed in the etripamil group versus 53.5 min in the placebo group. Treatment-emergent adverse events were mild or moderate and primarily included transient nasal discomfort, nasal congestion, and rhinorrhea. If etripamil is approved by the US FDA, it can potentially address a significant unmet need for PSVT treatment outside a clinical setting, reducing the need for intravenous treatments that require medical supervision. Podcast available for this article.https://doi.org/10.1007/s40119-023-00335-4Atrioventricular node-dependent tachycardiaCalcium channel blockersEtripamilIntranasal sprayParoxysmal supraventricular tachycardia |
| spellingShingle | Bruce S. Stambler James E. Ip Podcast on Self-administered Intranasal Etripamil for Symptomatic Paroxysmal Supraventricular Tachycardia: The RAPID Trial Cardiology and Therapy Atrioventricular node-dependent tachycardia Calcium channel blockers Etripamil Intranasal spray Paroxysmal supraventricular tachycardia |
| title | Podcast on Self-administered Intranasal Etripamil for Symptomatic Paroxysmal Supraventricular Tachycardia: The RAPID Trial |
| title_full | Podcast on Self-administered Intranasal Etripamil for Symptomatic Paroxysmal Supraventricular Tachycardia: The RAPID Trial |
| title_fullStr | Podcast on Self-administered Intranasal Etripamil for Symptomatic Paroxysmal Supraventricular Tachycardia: The RAPID Trial |
| title_full_unstemmed | Podcast on Self-administered Intranasal Etripamil for Symptomatic Paroxysmal Supraventricular Tachycardia: The RAPID Trial |
| title_short | Podcast on Self-administered Intranasal Etripamil for Symptomatic Paroxysmal Supraventricular Tachycardia: The RAPID Trial |
| title_sort | podcast on self administered intranasal etripamil for symptomatic paroxysmal supraventricular tachycardia the rapid trial |
| topic | Atrioventricular node-dependent tachycardia Calcium channel blockers Etripamil Intranasal spray Paroxysmal supraventricular tachycardia |
| url | https://doi.org/10.1007/s40119-023-00335-4 |
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